BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERYX PROCEDURE KIT

    MDR report key: 1333204 · Received March 5, 2009

    Report

    Report Number
    3005099803-2008-01924
    Event Type
    Injury
    Date Received
    March 5, 2009
    Date of Event
    August 4, 2005
    Report Date
    August 15, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH
    Product Code
    LMN
    PMA / PMN Number
    P020006
    Removal / Correction Number
    Z-0040-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, A DEVICE EVALUATION CANNOT BE PERFORMED. NOTE: THIS PRODUCT WAS REMOVED FROM THE GLOBAL MARKET IN SEPTEMBER 2005. BOSTON SCIENTIFIC CORPORATION NO LONGER PRODUCES THE REPORTED PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 15, 2005 THAT AN ENTERYX PROCEDURE KIT WAS IMPLANTED IN A PATIENT IN 2005 (PATIENT AGE, GENDER AND WEIGHT ARE UNKNOWN). EIGHT INJECTIONS WERE PERFORMED, DELIVERING A TOTAL OF 6.0CC'S OF ENTERYX SOLUTION TO THE PATIENT . OF THE TOTAL SOLUTION DELIVERED, 2.8CC'S WERE INJECTED SUBMUCOSALLY. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED BLEEDING FROM THE INJECTION SITE OF MILD INTENSITY ON THE DAY OF THE PROCEDURE. THE PATIENT WAS TREATED WITH AN INJECTION OF 8.0CC'S OF EPINEPHRINE INJECTED INTO THE BLEEDING SITE AND THE BLEEDING HAD RESOLVED BEFORE THE SCOPE WAS REMOVED FROM THE SITE. THE PATIENT WAS REPORTED TO BE DOING FINE AND NO DILATIONS WERE REQUIRED. NO WEIGHT LOSS WAS REPORTED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERYX PROCEDURE KIT CERAMICS, CALCIUM TRIPHOSPHATE/HYDROXYPATITE, NON-LOAD BEARING USES LMN BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH M00572600 40611

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention